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Effects of implantable cardioverter/defibrillator (ICD) shocks and antitachycardia pacing (ATP) on anxiety and quality of life (QoL) in ICD patients are poorly understood. We evaluated changes in QoL from baseline to 9-month follow-up using the EQ-5D questionnaire in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial—Reduce Inappropriate Therapy (MADIT-RIT) (n=1,268). We assessed anxiety levels using the Florida Shock Anxiety Scale (1-10 score) in patients with appropriate or inappropriate shocks or ATP compared to those with no ICD therapy during the first 9 months postimplant. The analysis was stratified by number of ATP or shocks (0-1 vs ≥2) and adjusted for covariates. In MADIT-RIT, 15 patients (1%) had ≥2 appropriate shocks, 38 (3%) had ≥2 appropriate ATPs. Two or more inappropriate shocks were delivered in 16 patients (1%); ≥2 inappropriate ATPs, in 70. In multivariable analysis, patients with ≥2 appropriate shocks had higher levels of shock-related anxiety than those with ≤1 appropriate shock (P<.01). Furthermore, ≥2 inappropriate shocks produced more anxiety than ≤1 inappropriate shock (P=.005). Consistently, ≥2 appropriate ATPs resulted in more anxiety than ≤1 (P=.028), whereas the number of inappropriate ATPs showed no association with anxiety levels (P=.997). However, there was no association between QoL and appropriate or inappropriate ATP/shock (all P values > .05). In MADIT-RIT, ≥2 appropriate or inappropriate ICD shocks and ≥2 appropriate ATPs are associated with more anxiety at 9-month follow-up despite no significant changes in the assessment of global QoL by the EQ-5D questionnaire. Innovative ICD programming reducing inappropriate therapies may help deal with patient concerns about the device.

In patients with reduced ejection fraction, mild heart failure, and prolonged QRS duration, CRT with a defibrillator improved survival, as compared with defibrillator therapy alone. The survival benefit was limited to patients with left bundle-branch block. The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) showed the safety and effectiveness of cardiac-resynchronization therapy (CRT) with a defibrillator (CRT-D) in patients with asymptomatic or mildly symptomatic heart failure, a reduced ejection fraction, and a prolonged QRS duration. 1 The study showed that treatment with CRT-D was associated with a 34% relative reduction in the risk of nonfatal heart-failure events or death from any cause, as compared with implantable cardioverter–defibrillator (ICD) therapy alone over a median follow-up period of 2.4 years. The benefit of CRT-D in the trial was primarily driven by a significant relative reduction of . . .

Background Patients undergoing cardiac resynchronization therapy with a defibrillator (CRT‐D) often experience improvements in the left ventricular ejection fraction (LVEF). This study aimed to identify predictors of ventricular tachyarrhythmias (VTA) in patients with CRT‐D devices and LVEF improvement beyond guideline recommendations for a defibrillator. Methods Patients randomized to the CRT‐D arm of the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy trial who improved their LVEF to > 35% at 12 months following CRT‐D implant were included in this analysis (N = 651). Predictors of an appropriate implantable cardioverter defibrillator (ICD) Rx VTA were evaluated by Cox proportional hazards regression modeling. Results We identified three predictors of VTA among patients treated with CRT‐D subsequent to LVEF improvement > 35%: Lower range improvement in LVEF 36%–40% versus improvement to > 40% (HR, 1.97; 95% CI, 1.21–3.20; p = 0.006); Baseline non‐LBBB ECG morphology (hazard ratio [HR], 1.93; 95% confidence interval [CI], 1.23–3.04; p = 0.004); Occurrence of VTA during the first year post‐CRT‐D (HR, 4.91; 95% CI, 2.99–8.07; p < 0.001). Conclusions We identified a sub‐group of patients with risk factors who remain at high risk of VTA despite improvement in LVEF following CRT implant. These patients require close monitoring despite improvement in LVEF beyond guideline recommendations for an ICD. In CRT‐D patients with LVEF above guideline indications, LVEF 36%–40%, absence of LBBB, and a history of VTA increase the risk for future VTA. These patients require close monitoring despite improvement beyond guideline recommendations.

Background Randomized trials in Western countries have provided evidence that prophylactic implantable cardioverter‐defibrillator (ICD) therapy reduces mortality in heart failure (HF) patients with reduced left ventricular ejection fraction. However, the risk of life‐threatening ventricular arrhythmias in Japanese HF patients sharing similar risk factors is still unknown. Methods The Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan trial (NCT03185832) is a prospective, multicenter registry designed to collect data on ventricular arrhythmia, HF events, and mortality in Japanese HF patients. Japanese patients with HF and 2‐5 predefined risk factors who were indicated for cardiac device implantation based on European Society of Cardiology guidelines were enrolled in four treatment arms: implantable cardioverter‐defibrillator (ICD), cardiac resynchronization therapy defibrillator (CRT‐D), HF pacing (PA; Pacemaker and cardiac resynchronization pacemaker), and nondevice (ND) cohorts and followed for a minimum of 12 months. Since it is anticipated that some baseline patient characteristics and risk factors will differ significantly from those reported in predominantly Western populations, event rates will be compared to a propensity‐matched population from the MADIT RIT trial. Primary endpoints are composite rates of first appropriately treated ventricular arrhythmias (VA) or/and life‐threatening VA symptoms for the ICD and CRT‐D cohorts. For nondevice and PA cohorts, the primary outcome is all‐cause mortality. Conclusions The Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan is a large prospective multicenter registry with defined device treatment cohorts and will provide data for risk stratification for cardiovascular events in Japanese HF patients.

BackgroundThe prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death.Methods and results781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription (p < 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown.ConclusionsMortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation.Graphic abstract

Limited data assessing the clinical significance of post-left ventricular assist device (LVAD) in renal function are available. We aimed to investigate the impact of changes in renal function after LVAD implantation on subsequent long-term outcomes. We followed 184 patients with HeartMate II LVADs implanted between May 2008 and November 2014. Serial assessment of renal function, was performed at baseline and at day 1, day 7, 1 month, 3 months, 6 months, 1 year, and 2 years after implantation. Effects of 1-month GFR and changes in GFR from baseline to 1 month on long-term mortality and hospital re-admission were evaluated. There were 30 patients with GFR <45 (low), 44 with GFR 45 to 59 (intermediate), and 110 with GFR ≥60 (normal) at baseline. Only patients with baseline GFR <45 experienced significant improvement in GFR after 2 years of follow-up (p = 0.012). At 1 month, a higher GFR category was significantly associated with a 31% reduction in mortality (hazard ratio [HR] 0.69, CI 0.49 to 0.98, p = 0.036), but not re-admission. Patients with baseline low and intermediate GFR who had no improvement in renal function category at 1 month experienced significantly greater risk of mortality (HR 1.95, CI 1.10 to 3.43, p = 0.022) and re-admission (HR 1.75, CI 1.07 to 2.84, p = 0.025), relative to patients whose GFR was normal at baseline and 1 month. In conclusion, renal function after LVAD implantation improves in patients with GFR <45. Change in renal function from baseline to 1 month after implantation is a powerful marker of long-term outcomes.

Low systolic blood pressure (SBP) is associated with increased mortality and heart failure in patients with left ventricular dysfunction. Data on the relation between SBP measured following cardiac resynchronization therapy implantation and subsequent clinical events are limited. We hypothesized that assessment of systolic blood pressure at 12 months after cardiac resynchronization therapy can be used to identify patients with increased risk for adverse cardiovascular outcomes. The study population comprised 1000 patients who underwent cardiac resynchronization therapy implantation in MADIT-CRT. Outcomes were compared between patients with low (<110 mm Hg) and preserved SBP (≥110 mm Hg) at 1 year. At 1 year following cardiac resynchronization therapy, 800 patients (80%) had preserved systolic blood pressure. Kaplan-Meier survival analysis showed that the rate of heart failure or death during subsequent follow-up was significantly higher among patients with low SBP as compared with a preserved SBP at 12 months (2-year rates: 20% vs 12%, respectively; log-rank p value = 0.009 for the overall difference during follow-up). Consistently, multivariate analysis showed that patients with preserved SBP at 1 year had a 29% lower risk of HF or death when compared with the low SBP group (p = 0.024). The association between SBP measured following cardiac resynchronization therapy implantation and subsequent clinical events was more pronounced among patients with nonischemic cardiomyopathy (p value for SBP-by-HF etiology interaction = 0.034). In conclusion, assessment of SBP following cardiac resynchronization therapy can be used for improved long-term risk stratification in this population.

Right ventricular (RV) dysfunction has been associated with poor prognosis in chronic heart failure (HF). However, less data is available about the role of RV dysfunction in patients with cardiac resynchronization therapy (CRT). We aimed to investigate if RV dysfunction would predict outcome in CRT. We enrolled prospectively ninety-three consecutive HF patients in this single center observational study. All patients underwent clinical evaluation and echocardiography before CRT and 6 months after implantation. We assessed RV geometry and function by using speckle tracking imaging and calculated strain parameters. We performed multivariable Cox regression models to test mortality at 6 months and at 24 months. RV dysfunction, characterized by decreased RVGLS (RV global longitudinal strain) [10.2 (7.0-12.8) vs. 19.5 (15.0-23.9) %, p<0.0001] and RVFWS (RV free wall strain) [15.6 (10.0-19.3) vs. 17.4 (10.5-22.2) %, p = 0.04], improved 6 months after CRT implantation. Increasing baseline RVGLS and RVFWS predicted survival independent of other parameters at 6 months [hazard ratio (HR) = 0.37 (0.15-0.90), p = 0.02 and HR = 0.42 (0.19-0.89), p = 0.02; per 1 standard deviation increase, respectively]. RVGLS proved to be a significant independent predictor of mortality at 24 months [HR = 0.53 (0.32-0.86), p = 0.01], and RVFWS showed a strong tendency [HR = 0.64 (0.40-1.00), p = 0.05]. The 24-month survival was significantly impaired in patients with RVGLS below 10.04% before CRT implantation [area under the curve = 0.72 (0.60-0.84), p = 0.002, log-rank p = 0.0008; HR = 5.23 (1.76-15.48), p = 0.003]. Our findings indicate that baseline RV dysfunction is associated with poor short-term and long-term prognosis after CRT implantation.

Patients with diabetes mellitus, prior myocardial infarction, older age, and a relatively preserved left ventricular ejection fraction remain at risk for sudden cardiac death that is potentially amenable by the subcutaneous implantable cardioverter defibrillator with a good risk-benefit profile. The launched MADIT S-ICD study is designed to test the hypothesis that post–myocardial infarction diabetes patients with relatively preserved ejection fraction of 36%-50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator.

Guidelines support cardiac resynchronization therapy with a defibrillator (CRT-D) in mild heart failure (HF) patients with left bundle branch block (LBBB). However, not all patients demonstrate echocardiographic or clinical response to CRT-D. We aimed to evaluate the long-term outcomes of echocardiographic hypo-responders and clinical hypo-responders to CRT-D with LBBB in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy. Five-hundred thirty-four patients with LBBB in the CRT-D arm were followed for 5.6 years (median). Clinical hypo-response was defined as HF event in the first year after CRT-D implantation. Echocardiographic hypo-response was defined as ≤35% reduction (median) in left ventricular end-systolic volume 1 year after CRT-D implantation without evidence of clinical hypo-response. Echocardiographic and clinical response was observed in 257 patients (48%). Two-hundred fifty patients (47%) were echocardiographic hypo-responders and 27 patients (5%) were clinical hypo-responders. Echocardiographic hypo-responders had increased risk of all-cause mortality compared with echocardiographic + clinical responders (hazard ratio [HR] 2.85, 95% confidence interval [CI]: 1.37 to 5.94, p = 0.005). Clinical hypo-responders had increased risk of mortality compared with echocardiographic + clinical responders (HR 7.49, 95% CI: 2.88 to 19.48, p <0.0001) and compared with echocardiographic hypo-responders (HR 2.63, 95% CI: 1.17 to 5.92, p = 0.020). In conclusion, during long-term follow-up, patients with mild HF and LBBB who have echocardiographic hypo-response to CRT, with or without clinical signs of worsening HF, have increased risk of mortality. This study emphasizes the prognostic significance of echocardiographic assessment of left ventricular volume after CRT implantation in LBBB patients with mild HF.